WO2023199568A1 - Dispositif de perforation - Google Patents
Dispositif de perforation Download PDFInfo
- Publication number
- WO2023199568A1 WO2023199568A1 PCT/JP2023/002360 JP2023002360W WO2023199568A1 WO 2023199568 A1 WO2023199568 A1 WO 2023199568A1 JP 2023002360 W JP2023002360 W JP 2023002360W WO 2023199568 A1 WO2023199568 A1 WO 2023199568A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- puncture
- core material
- puncturing
- tip
- section
- Prior art date
Links
- 239000011162 core material Substances 0.000 claims abstract description 69
- 230000002093 peripheral effect Effects 0.000 claims abstract description 15
- 238000003780 insertion Methods 0.000 claims description 18
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
Definitions
- the present invention relates to a puncturing device for an endoscope.
- EUS ultrasound endoscope
- EUS-BD endoscopic ultrasound biliary drainage
- EUS-HGS an endoscopic puncturing device including a sheath and a puncturing needle is used together with an ultrasound endoscope.
- Patent Document 1 discloses an endoscopic puncture device used for such treatment.
- the endoscopic puncture device of Patent Document 1 includes a thin stainless steel pipe or other metal pipe material, etc., inside a flexible sheath that is inserted into the inside of the ultrasonic endoscope (treatment instrument insertion channel).
- a puncture needle using a needle is inserted through the puncture needle.
- the present invention has been made in view of these points, and an object of the present invention is to provide a puncturing device that has high puncturing performance and safety.
- the present invention includes a puncture section having a sharp needle tip, and a shaft section provided on the proximal end side of the puncture section, the shaft section being connected to a core material. , and an outer layer body disposed on the outer peripheral surface of the core material (invention 1).
- the flexibility of the shaft portion can be easily increased by changing the diameter of the core material and the thickness of the outer layer. Since the shaft portion can be adjusted to be more flexible than the puncturing portion, it is possible to provide a puncturing device with high puncturing performance and safety.
- the outer layer on the outer peripheral surface of the core material, the diameter of the core material and the thickness of the outer layer can be changed to make the outer diameter of the puncture part and the outer diameter of the shaft uniform. Can be configured.
- the tip of the core material may be located inside the puncture part (invention 2).
- invention 2 it is possible to join the puncture part and the shaft part more stably than by simply bringing the puncture part and the shaft part into contact and joining them at a surface.
- the tip of the core material may be inserted into an insertion hole formed in the puncture part (invention 3).
- the rear end of the puncture portion and the tip of the outer layer may be in contact with each other (invention 4).
- the outer diameter of the puncture portion and the outer diameter of the shaft portion may be substantially the same (invention 5).
- FIG. 1 is an explanatory diagram showing the overall structure of a puncture device according to a first embodiment.
- FIG. 2 is an explanatory diagram showing the structure of the distal end portion of the puncture device according to the first embodiment.
- FIG. 7 is an explanatory diagram showing the structure of a distal end portion of a puncture device according to a second embodiment.
- FIG. 7 is an explanatory diagram showing the structure of the tip of a puncture device according to a third embodiment.
- FIG. 1 is an explanatory diagram showing the overall structure of the puncturing device 1 according to the first embodiment
- FIG. 2 is an explanatory diagram showing the structure of the distal end portion (the part surrounded by a broken line in FIG. 1) of the puncturing device 1.
- distal end side refers to a direction along the axial direction of the puncture device 1, and a direction in which the puncture device 1 and an endoscope (not shown) equipped with it proceed toward the puncture target site. means.
- proximal side refers to a direction along the axial direction of the puncture device 1, and means a direction opposite to the distal end side.
- distal end refers to the distal end of any member or site
- base end refers to the proximal end of any member or site.
- distal end refers to a part of any member or part that includes the distal end and extends from the distal end towards the proximal end to the middle of the member, etc.; Refers to a part of a member or part that includes its base end and extends from the base end toward the distal end to the middle of the member.
- the left side of the figure is the “distal side” that is inserted into the body, and the right side of the figure is the "proximal side” that is operated by the operator.
- the puncture device 1 includes a needle member 10, an inner sheath 20, an outer sheath 30, and an operating section 40.
- the puncture device 1 forms a puncture hole by piercing the peripheral wall of a hollow organ (for example, the stomach or liver) to be connected by bypass with the tip of the needle member 10, and inserts the needle through the puncture hole. , used when inserting a guide wire between hollow organs.
- the outer sheath 30 (and the inner sheath 20 and the needle member 10 incorporated in the inner lumen of the outer sheath 30) are inserted into a treatment tool insertion channel of an endoscope (not shown), and the operating section 40 is inserted into the treatment tool insertion channel of an endoscope (not shown).
- the outer sheath 30 is configured to be able to slide (relatively move) in the axial direction with respect to the treatment instrument insertion channel of the endoscope.
- the distal end of the puncture device 1 protrudes from the distal end of the treatment instrument insertion channel of the endoscope.
- the inner sheath 20 is a flexible, elongated tubular member, and the needle member 10 is inserted into its lumen.
- the inner diameter of the inner sheath 20 is equal to or slightly larger than the outer diameter of the needle member 10 so that the needle member 10 can slide (relatively move) in the axial direction within the lumen of the inner sheath 20.
- the outer diameter of the inner sheath 20 is formed to be slightly smaller than the inner diameter of the outer sheath 30 so that the inner sheath 20 can slide (relatively move) in the axial direction within the lumen of the outer sheath 30, which will be described later. has been done.
- the material forming the inner sheath 20 is not particularly limited as long as it has enough strength to withstand the sliding of the needle member 10 within its lumen and is biocompatible.
- various resin materials such as polyethylene, polypropylene, polyvinyl chloride, polystyrene, acrylic resin, phenol resin, melamine resin, polyimide, polyamide, polycarbonate, polyether sulfone, polyether ether ketone, polytetrafluoroethylene, and polystyrene
- Various thermoplastic elastomers can be used, such as thermoplastic elastomers, polyolefin-based, polyurethane-based, polyester-based, polyamide-based, and polybutadiene-based. Two or more of these can also be used in combination.
- the inner sheath 20 can be slid (relatively moved) in the axial direction with respect to the outer sheath 30 by operating the operating section 40.
- the outer sheath 30 is a flexible, elongated tubular member, and the inner sheath 20 is inserted into its lumen.
- the inner diameter of the outer sheath 30 is formed to be slightly larger than the outer diameter of the inner sheath 20 so that the inner sheath 20 can slide (relatively move) in the axial direction within the lumen of the outer sheath 30.
- the outer sheath 30 has an outer diameter large enough to be inserted into a treatment instrument insertion channel of an endoscope (not shown).
- the material forming the outer sheath 30 is not particularly limited as long as it has enough strength to withstand the sliding of the inner sheath 20 within its lumen and is biocompatible.
- the materials exemplified as materials for forming the inner sheath 20 can be used.
- the outer sheath 30 can be slid (relatively moved) in the axial direction with respect to the treatment instrument insertion channel of the endoscope by operating the operating section 40.
- the operating section 40 is composed of a plurality of members made of, for example, a resin material, and is provided slidably with respect to the operating section main body 41 to which the proximal end of the outer sheath 30 is fixed. It has a slider section 42. All the members constituting the operating section 40 may be made of the same material, or may be partially made of different materials.
- the operating section main body 41 has an elongated cylindrical shape as a whole, and includes a connecting section 411 that is connected and fixed to the entrance of the treatment instrument insertion channel of the endoscope, and an outer sheath that is connected to the proximal end side of the connecting section 411. It includes a length adjustment section 412 and an inner sheath length adjustment section 413 connected to the proximal end side of the outer sheath length adjustment section 412.
- the connecting part 411 is fixed to the distal end of the scale part 4121 of the outer sheath length adjusting part 412 by adhesive or other means, and the proximal end of the outer sheath 30 is fixed thereto.
- the connecting portion 411 is connected and fixed to the entrance of the treatment instrument insertion channel of the endoscope, thereby making it possible to fix the puncture device 1 to the endoscope.
- the outer sheath length adjustment section 412 is a mechanism for adjusting the positional relationship between the endoscope and the outer sheath 30, and includes a scale section 4121 and a stopper 4122.
- the stopper 4122 is arranged to be slidable with respect to the scale portion 4121.
- the scale portion 4121 has a plurality of scales that serve as indicators for setting the placement position of the stopper 4122, and each scale is arranged at a predetermined interval on the outer peripheral surface of the scale portion 4121. Each scale represents the length from the tip of the connecting portion 411 to the tip of the outer sheath 30.
- the inner sheath length adjustment section 413 is a mechanism for adjusting the positional relationship between the outer sheath 30 and the inner sheath 20 (and the needle member 10 incorporated in the inner lumen of the inner sheath 20), and the scale section 4131 and a stopper 4132.
- the stopper 4132 is arranged to be slidable with respect to the scale portion 4131.
- the scale portion 4131 has a plurality of scales that serve as indicators for setting the placement position of the stopper 4132, and each scale is arranged at a predetermined interval on the outer peripheral surface of the scale portion 4131.
- Each scale represents the protrusion length of the inner sheath 20 (and the needle member 10 incorporated into the inner lumen of the inner sheath 20) from the tip of the outer sheath 30, and for example, the scale corresponding to the numerical value "1" Place the stopper 4132 at the position and fix it by turning the screw. If the slider section 42 is slid toward the distal end in this state, it is possible to make the distal end of the inner sheath 20 (and needle member 10) protrude from the distal end of the outer sheath 30 by the length (1 cm) indicated by the scale. It has become.
- the slider portion 42 has an elongated cylindrical shape as a whole, and includes a handle portion 421 that is grasped by the user, and a proximal end portion of the needle member 10 connected to the proximal end side of the handle portion 421.
- a needle fixing part 422 is provided.
- the needle member 10 includes a puncture section 11 having a solid structure having a needle tip 111 with a sharp tip, and a shaft section 12 provided on the proximal end side of the puncture section 11. Equipped with.
- the length of the puncture section 11 is approximately 5 to 80 mm, and the length of the shaft section 12 varies depending on the use of the puncture device 1 and the like.
- the puncture section 11 includes a substantially triangular pyramid-shaped needle tip 111 with a triangularly pointed tip and a cylindrical base 112 that is integrally formed with the needle tip 111.
- An insertion hole 113 that opens in the direction toward 12 (proximal direction) is formed.
- the material forming the puncture part 11 is not particularly limited as long as it has enough hardness and strength to form a puncture hole by penetrating the needle tip 111 into the site to be punctured, and is biocompatible.
- metal materials such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, etc. can be used, although this is not limited to specific materials.
- the maximum outer diameter of the needle tip 111 of the puncture part 11 needs to be the same as or smaller than the outer diameter of the base part 112 so that the puncture part 11 does not get caught on the inner sheath 20 when the needle member 10 is pulled out from the inner sheath 20. be.
- the shaft portion 12 includes a core material 121 having a substantially uniform diameter over its entire length and a substantially circular cross section, and an outer layer body 122 disposed on the outer peripheral surface of the core material 121.
- the outer diameter of the outer layer 122 is approximately the same as the outer diameter of the base 112 of the puncture section 11, and the outer circumferential surface from the base 12 of the puncture section 11 to the entire outer layer 122 is aligned with the inner circumference of the inner sheath 20.
- the needle member 10 is inserted into the lumen of the inner sheath 20 so as to be in contact with the inner sheath 20.
- the distal end 1211 of the core material 121 is inserted into the insertion hole 113 formed in the base 112 of the puncture section 11. As a result, at least a portion of the core material 121 (the distal end portion 1211) is located inside the puncture portion 11.
- the distal end 1211 of the core material 121 may be fixed to the base 112 of the puncture section 11 using known fixing means.
- the material forming the core material 121 is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11 can be used.
- the core material 121 may be made entirely of the same material, or may be partially made of different materials.
- the puncture section 11 and the shaft section 12 can be simply brought into contact with each other and the surface The two can be joined more stably than if they were joined together.
- the outer layer 122 of the shaft portion 12 is a wire rope in which a plurality of wires (wires or groups of wires) are twisted spirally and arranged around the core material 121.
- the material forming the outer layer body 121 is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11 can be used.
- the outer layer body 121 may be entirely formed of the same material, or may be partially formed of different materials.
- the distal end of the outer layer body 122 (the distal end surface of the outer layer body 122) is in contact with the proximal end of the puncture section 11 (the proximal end surface of the base portion 112 of the puncture section 11), and the base end of the puncture section 11 and the proximal end surface of the outer layer body 122 are in contact with
- the tip is fixed using a known joining means such as adhesive, brazing, pressure welding, YAG laser welding, or the like.
- the outer layer body 122 is disposed on the outer peripheral surface of the core material 121 like the shaft portion 12 of the needle member 10 described above, by changing the diameter of the core material 121 and the thickness of the outer layer body 122, Since the flexibility of the shaft section 12 can be easily adjusted, the shaft section 12 can be formed to be more flexible than the puncture section 11, and as a result, the puncture device 1 having high puncture performance and safety is provided. be able to.
- the outer layer body 122 on the outer circumferential surface of the core material 121, the diameter of the core material 121 and the thickness of the outer layer body 122 can be changed.
- the outer diameter of the needle member 10 can be made uniform (that is, the outer diameter of the needle member 10 can be made uniform as a whole).
- the shaft part 12 is formed to be more flexible than the puncture part 11, when performing a puncture procedure using the puncture device 1, even if the needle member 10 is pushed out while the endoscope is at an up angle. Since the needle member 10 itself can be prevented from being bent and deformed, it is possible to completely and smoothly form a hole in the puncture target site, and to provide a puncturing device 1 having high puncturing performance and safety. be able to.
- a puncturing device 1A according to the second embodiment has the needle member 10 of the puncturing device 1 according to the first embodiment replaced with a needle member 10A having the structure described below.
- the structures of the inner sheath 20, the outer sheath 30, and the operating section 40 are the same as those of the puncture device 1 according to the first embodiment, so the description thereof will be omitted.
- FIG. 3 is an explanatory diagram showing the structure of the tip of the puncture device 1A according to the second embodiment.
- the needle member 10A according to the present embodiment includes a puncturing part 11A having a solid structure having a needle tip 111 with a sharp tip, and a shaft part 12A provided on the proximal end side of the puncturing part 11A. Equipped with.
- the length of the puncture portion 11A is approximately 5 to 80 mm, and the length of the shaft portion 12A varies depending on the use of the puncture device 1, etc.
- the puncture section 11A includes a substantially triangular pyramid-shaped needle tip 111A with a triangularly pointed tip, and a cylindrical base portion 112A that is integrally formed with the needle tip 111A.
- An insertion hole 113A that opens in the direction toward 12A (proximal direction) is formed.
- the material forming the puncture part 11A is particularly limited as long as it has enough hardness and strength to form a puncture hole by penetrating the needle tip 111A into the puncture target site, and is biocompatible.
- metal materials such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, etc. can be used, although this is not limited to specific materials.
- the shaft portion 12A includes a core material 121A having a substantially circular cross section with a core tip portion 1213A having a smaller diameter than the core body portion 1211A, and an outer layer body 122A disposed on the outer peripheral surface of the core material 121A. Equipped with The outer diameter of the outer layer body 122A is approximately the same as the outer diameter of the puncture part 11A, and the needle member is arranged such that the outer peripheral surface from the puncture part 11A to the entire outer layer body 122A is in contact with the inner peripheral surface of the inner sheath 20. 10A is inserted into the lumen of the inner sheath 20.
- the core material 121A includes a core body portion 1211A having a substantially cylindrical shape, a core taper portion 1212A having a tapered shape (truncated cone shape) whose outer diameter gradually decreases, and a substantially cylindrical core having an outer diameter smaller than the core body portion 1211A.
- the tip portion 1213A is provided.
- the outer diameter of the core body 1211A is equal to the inner diameter of the outer layer 122A, and the outer diameter of the core tip 1213A is equal to the inner diameter of the insertion hole 113A of the puncture section 11A.
- the distal end portion 1213A of the core material 121A is inserted into the insertion hole 113A of the puncture portion 11A. As a result, at least a portion (the distal end portion 1211A) of the core material 121A is located inside the puncture portion 11A.
- the distal end portion 1213A of the core material 121A may be fixed to the puncture portion 11A using a known fixing means.
- the material forming the core material 121A is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11A can be used.
- the core material 121A may be entirely formed of the same material, or may be partially formed of different materials.
- the outer layer 122A of the shaft portion 12A is a wire rope in which a plurality of wires (wires or groups of wires) are twisted in a spiral shape and arranged around the core material 121A.
- the material forming the outer layer body 121A is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11A can be used.
- the outer layer body 121A may be entirely formed of the same material, or may be partially formed of different materials.
- the distal end of the outer layer 122A is in contact with the proximal end of the puncture section 11A, and the proximal end of the puncture section 11A and the distal end of the outer layer 122A are bonded together using known methods such as adhesive, brazing, pressure welding, YAG laser welding, etc. It is fixed using a joining means.
- the outer diameter of the entire shaft portion can be maintained. Since a core material with a larger diameter can be used for the shaft portion, the degree of freedom in adjusting the flexibility provided to the shaft portion can be increased.
- a puncturing device 1B according to the third embodiment replaces the needle member 10 of the puncturing device 1 according to the first embodiment with a needle member 10B having the structure described below.
- the structures of the inner sheath 20, the outer sheath 30, and the operating section 40 are the same as those of the puncture device 1 according to the first embodiment, so the description thereof will be omitted.
- FIG. 4 is an explanatory diagram showing the structure of the tip of the puncture device 1B according to the third embodiment.
- the needle member 10B according to the present embodiment includes a puncture section 11B having a hollow structure and a shaft section 12B provided on the proximal end side of the puncture section 11B.
- the length of the puncture portion 11B is approximately 5 to 80 mm, and the length of the shaft portion 12B varies depending on the use of the puncture device 1 and the like.
- the puncture portion 11B has a blade surface 115 formed by cutting a substantially cylindrical member having a through hole 114 having a circular cross-sectional shape along the axis at an angle to the axis at the distal end thereof. .
- the material forming the puncture part 11B is not particularly limited as long as it has enough hardness and strength to allow the blade surface 115 to penetrate the puncture target site and form a puncture hole, and is biocompatible.
- metal materials such as stainless steel, titanium, nickel-titanium alloy, cobalt-chromium alloy, etc. can be used, although this is not limited to specific materials.
- the shaft portion 12B includes a core material 121B having a substantially circular cross section with a core tip portion 1213B having a smaller diameter than the core body portion 1211B, and an outer layer body 122B disposed on the outer peripheral surface of the core material 121B. Equipped with The outer diameter of the outer layer body 122B is approximately the same as the outer diameter of the puncture part 11B, and the needle member is arranged such that the outer circumferential surface from the puncture part 11B to the entire outer layer body 122B is in contact with the inner circumferential surface of the inner sheath 20. 10B is inserted into the lumen of the inner sheath 20.
- the core material 121B includes a core main body portion 1211B having a substantially cylindrical shape, a core taper portion 1212B having a tapered shape (truncated cone shape) with an outer diameter gradually decreasing, and a substantially cylindrical core having an outer diameter smaller than the core main body portion 1211B.
- the tip portion 1213B is provided.
- the outer diameter of the core body portion 1211B is equal to the inner diameter of the outer layer body 122B, and the outer diameter of the core tip portion 1213B is equal to the inner diameter of the through hole 114 of the puncture portion 11B.
- the tip portion 1213B of the core material 121B is inserted into the through hole 114 of the puncture portion 11B. As a result, at least a portion (tip portion 1211B) of the core material 121B is located inside the puncture portion 11B.
- the distal end portion 1213B of the core material 121B may be fixed to the puncture portion 11B using a known fixing means.
- the material forming the core material 121B is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11B can be used.
- the core material 121B may be entirely formed of the same material, or may be partially formed of different materials.
- the outer layer 122B of the shaft portion 12B is a wire rope in which a plurality of wires (wires or groups of wires) are twisted spirally and arranged around the core material 121B.
- the material forming the outer layer body 121B is not particularly limited, but for example, the same metal material as the material forming the puncture portion 11B can be used.
- the outer layer body 121B may be entirely formed of the same material, or may be partially formed of different materials.
- the distal end of the outer layer body 122B is in contact with the proximal end of the puncture section 11B, and the proximal end of the puncture section 11B and the distal end of the outer layer body 122B are bonded together using a known method such as adhesive, brazing, pressure welding, YAG laser welding, etc. It is fixed using a joining means.
- the outer diameter of the entire shaft portion can be maintained. Since a core material with a larger diameter can be used for the shaft portion, the degree of freedom in adjusting the flexibility provided to the shaft portion can be increased.
- a hollow puncturing part with a through hole formed along the axis like the puncturing part 11B according to the present embodiment, it functions as a biopsy needle that collects a tissue piece from the puncturing target site. can be held at the puncture site.
- the puncturing device has been described above based on the drawings, the present invention is not limited to the above embodiments, and various modifications can be made.
- a wire rope formed by twisting a plurality of wires in a spiral is used as the outer layer 122 of the shaft portion 12, but the wire rope is not limited to this.
- a tube body or a coil body formed of, for example, a metal material or a resin material is adopted as the outer layer body 122, so that the flexibility of the shaft portion 12 is higher than that of the puncture portion 11. You may do so.
- the tip part 1211 of the core material 121 inserted into the insertion hole 113 of the puncture part 11 is laser-coupled from the outer surface of the puncture part 11.
- the joint strength may be increased by spot welding, or a groove may be cut from the outer surface of the puncture portion 11, and the tip portion 1211 of the core material 121 may be inserted and buried in the groove.
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Abstract
L'invention concerne un dispositif de perforation (1) pourvu : d'une partie de perforation (11) qui présente une pointe d'aiguille ayant une forme pointue ; et d'une partie tige (12) qui est disposée sur le côté d'extrémité proximale de la partie de perforation (11). La partie tige (12) est pourvue : d'un matériau central (121) ; et d'un corps de couche externe (122) disposé sur la surface périphérique extérieure du matériau central (121). Selon la présente invention, un dispositif de perforation peut être obtenu, lequel a une performance de perforation élevée et une performance de sécurité élevée.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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CN212281544U (zh) * | 2019-03-22 | 2021-01-05 | 北京爱琳医疗科技有限公司 | 一种穿刺导入系统及其穿刺针 |
CN212490011U (zh) * | 2019-12-31 | 2021-02-09 | 杭州德晋医疗科技有限公司 | 经导管途径的瓣膜缝线器械及其穿刺针 |
DE102019212203A1 (de) * | 2019-08-14 | 2021-02-18 | Richard Wolf Gmbh | Lichtapplikatorsystem |
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CN212281544U (zh) * | 2019-03-22 | 2021-01-05 | 北京爱琳医疗科技有限公司 | 一种穿刺导入系统及其穿刺针 |
DE102019212203A1 (de) * | 2019-08-14 | 2021-02-18 | Richard Wolf Gmbh | Lichtapplikatorsystem |
CN212490011U (zh) * | 2019-12-31 | 2021-02-09 | 杭州德晋医疗科技有限公司 | 经导管途径的瓣膜缝线器械及其穿刺针 |
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